Physician-Patient Communication Project

NCT01530867 | Completed DMC

• 1 other identifier: R01AT005883-02
• Study Type: observational
• Target: 456
• Locations: 1 country
• Sites: 5

Brief Summary

Over half of all Americans take dietary supplements (vitamins, minerals, herbal products) along with their prescription medications. With the economic downturn, dietary supplement sales have surged, perhaps as a result of people attempting to stave off or delay medical care. Supplements are generally thought to be harmless, but some can potentially interact with prescription medications, cause liver or kidney damage, and even adversely affect surgical outcomes. Those substituting dietary supplements for prescription medications also may suffer significant adverse consequences. The United States Food and Drug Administration and the Institute of Medicine recommend that patients considering dietary supplement use consult their providers. Unfortunately, patients fail to disclose dietary supplement use in up to two-thirds of outpatient office visits. To improve discussions, it is important to understand what prompts physicians and patients to communicate about dietary supplements. The overall objectives of this application are to understand how, when and why physicians and patients communicate about dietary supplements, and to assess how patients respond to these discussions. An ethnically diverse group of patients and their physicians will be surveyed and their office visits will be audio recorded. Audio recordings of the visits will be used to assess the relationship of patient and physician attitudes and values, and the physician-patient relationship on dietary supplement discussions. A subset of these patients and physicians will be interviewed to explore how they made decisions to initiate or forgo discussions about supplements. They also will be asked questions concerning the necessity of and responsibility for initiating dietary supplement conversations. Patient responses and reactions to actual discussions also will be explored. Data from observed and reported interactions will be compared to provide a deeper understanding of factors related to disclosure. This project aims to provide a broad understanding of the content of physician-patient discussions about dietary supplements, and to describe how and why physician and patient attitudes and opinions affect these discussions. Identification of mutable factors can result in interventions to increase communication about dietary supplements, help maintain patient safety, and promote appropriate use of supplements concurrent with prescription medications.

Conditions

Dietary Supplements

Keywords

Dietary Supplements; Physician-patient communication; Qualitative study; Audio recorded office visits

Outcome Measures

Primary Outcomes (1)

• patients disclosing dietary supplement use

  Number of patients who disclosed dietary supplement use during audio recorded office visit

  Disclosure will be measured at a single time point - on the day the patient's office visit is audio recorded. A subset of patients will be selected for a semi-structured interview up to 1 week after the visit.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care physicians Integrative medicine / complementary and alternative medicine physicians Patients aged 18 and older of physicians participating in the study

You may qualify if:

• English or Spanish-speaking
• Aged 18 and older

You may not qualify if:

• Does not speak English or Spanish

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH): collaborator
• University of California, Los Angeles: lead

Study Sites (5)

Kaiser Permanente LAMC

Los Angeles, California, 90027, United States

Location

Center for East-West Medicine

Los Angeles, California, 90404, United States

Location

LA Net Practice Based Research Network

Los Angeles, California, 90808, United States

Location

Community-based provider offices

Los Angeles, California, United States

Location

University of California, Los Angeles

Santa Monica, California, 90404, United States

Location

Study Officials

• Derjung M Tarn, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 2, 2012
• First Posted: February 10, 2012
• Study Start: November 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: June 6, 2013

Record last verified: 2013-06

Locations

US (5)